Journal article
Authors list: Khanna, Dinesh; Furst, Daniel E.; Allanore, Yannick; Bae, Sangmee; Bodukam, Vijay; Clements, Philip J.; Cutolo, Maurizio; Czirjak, Laszlo; Denton, Christopher P.; Distler, Oliver; Walker, Ulrich A.; Matucci-Cerinic, Marco; Mueller-Ladner, Ulf; Seibold, James R.; Singh, Manjit; Tyndall, Alan
Publication year: 2015
Pages: 144-151
Journal: Rheumatology
Volume number: 54
Issue number: 1
ISSN: 1462-0324
eISSN: 1462-0332
Open access status: Green
DOI Link: https://doi.org/10.1093/rheumatology/keu288
Publisher: Oxford University Press
Methods. Thirteen international SSc experts experienced in SSc clinical trial design were invited to participate. One researcher with experience in systematic literature review and three trainees were also included. A systematic review using PubMed and the Cochrane Central Register of Controlled Trials was conducted and PTCs when designing clinical trials in SSc were developed. As part of that development we conducted an Internet-based Delphi exercise regarding the main points to be made in the consensus statement. Consensus was defined as achieving a median score of a parts per thousand yen7 of 9. Results. By consensus, the experts decided to develop PTCs for each individual organ system. The current document provides a unifying outline on PTCs regarding general trial design, inclusion/exclusion criteria and analysis. Consensus was achieved regarding all the main points of the PTCs. Conclusion. Using European League Against Rheumatism suggestions for PTCs, a general outline for PTCs for controlled clinical trials in SSc was developed. Specific outlines for individual organ systems are to be published separately. This general outline should lead to more uniform and higher-quality trials and clearly delineate areas where further research is needed.
Abstract:
Citation Styles
Harvard Citation style: Khanna, D., Furst, D., Allanore, Y., Bae, S., Bodukam, V., Clements, P., et al. (2015) Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards, Rheumatology, 54(1), pp. 144-151. https://doi.org/10.1093/rheumatology/keu288
APA Citation style: Khanna, D., Furst, D., Allanore, Y., Bae, S., Bodukam, V., Clements, P., Cutolo, M., Czirjak, L., Denton, C., Distler, O., Walker, U., Matucci-Cerinic, M., Mueller-Ladner, U., Seibold, J., Singh, M., & Tyndall, A. (2015). Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards. Rheumatology. 54(1), 144-151. https://doi.org/10.1093/rheumatology/keu288
Keywords
Clinical trials; CYCLOPHOSPHAMIDE; DOUBLE-BLIND; D-PENICILLAMINE; INTERSTITIAL LUNG-DISEASE; MULTICENTER; PLACEBO; points to consider; RECOMMENDATIONS; SCLERODERMA; Systemic sclerosis; TERM-FOLLOW-UP
